DESCRIPTION SECTION.


DESCRIPTION. Chemically, meclizine hydrochloride is 1-( p-chloro--phenylbenzyl)-4-( m-methylbenzyl) piperazine dihydrochloride monohydrate. 25H 27CIN 2.2HCl.H 20 M.W. 481.89 Meclizine hydrochloride tablets, USP are available in two different strengths, 12.5 mg and 25 mg. Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium and magnesium stearate. The 12.5 mg tablet also contains FD&C Blue Aluminum Lake.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Motion Sickness. The initial dose of 25 to 50 mg of meclizine hydrochloride should be taken one hour prior to embarkation for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Anaphylactoid reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision have been reported.

BOXED WARNING SECTION.


Based on review of this drug by the National Academy of Sciences National Research Council and/or other information, FDA has classified the indications as follows:Effective: Management of nausea and vomiting, and dizziness associated with motion sickness.Final classification of the less than effective indications requires further investigation.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. Meclizine hydrochloride is an antihistamine that shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has marked effect in blocking the vasodepressor response to histamine, but only slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.. Pharmacokinetics. The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.. Absorption. Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at median max value of hours post-dose (range: 1.5 to hours) for the tablet dosage form. Distribution. Drug distribution characteristics for meclizine in humans are unknown.. Metabolism. The metabolic fate of meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be the dominant enzyme for metabolism of meclizine.The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.. Elimination. Meclizine has plasma elimination half-life of about 5-6 hours in humans.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. Meclizine hydrochloride is contraindicated in individuals who have shown previous hypersensitivity to it.

HOW SUPPLIED SECTION.


HOW SUPPLIED. 25 mg, white, modified oval-shaped tablets, de-bossed 14 on one side and plain on the other side. They are supplied as follows: NDC 12634-424-00 Bottles of 10NDC 12634-424-01 Bottles of 100NDC 12634-424-09 Bottles of 35NDC 12634-424-12 Bottles of 120NDC 12634-424-18 Bottles of 180NDC 12634-424-40 Bottles of 40NDC 12634-424-42 Bottles of 42NDC 12634-424-45 Bottles of 45NDC 12634-424-50 Bottles of 50NDC 12634-424-52 Blister Pack of 12NDC 12634-424-54 Blister Pack of 14NDC 12634-424-57 Blister Pack of 20NDC 12634-424-59 Blister Pack of 30NDC 12634-424-60 Bottles of 60NDC 12634-424-61 Blister Pack of 10NDC 12634-424-63 Blister Pack of 3NDC 12634-424-66 Blister Pack of 6NDC 12634-424-67 Blister Pack of 7NDC 12634-424-69 Blister Pack of 9NDC 12634-424-71 Bottles of 30NDC 12634-424-74 Bottles of 24NDC 12634-424-78 Bottles of 28NDC 12634-424-79 Bottles of 25NDC 12634-424-80 Bottles of 20NDC 12634-424-81 Bottles of 21NDC 12634-424-82 Bottles of 12NDC 12634-424-84 Bottles of 14NDC 12634-424-85 Bottles of 15NDC 12634-424-90 Bottles of 90NDC 12634-424-91 Blister Pack of 1NDC 12634-424-92 Bottles of 2NDC 12634-424-93 Bottles of 3NDC 12634-424-94 Bottles of 4NDC 12634-424-95 Bottles of 5NDC 12634-424-96 Bottles of 6NDC 12634-424-97 Bottles of 7NDC 12634-424-98 Bottles of 8NDC 12634-424-99 Bottles of 9Store at 20o to 25oC (68 to 77oF) [See USP Controlled Room Temperature]. Dispense contents in tight, light-resistant container as defined in the USP, with child-resistant closure, as required.Manufactured by:Epic Pharma, LLCLaurelton, NY 11413Manufactured in USARevised January 2016MF012REV01/16OE1035Repackaged Distributed by:Apotheca Inc. Phoenix, AZ 85006.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 25 mg, 30 Tablets. Meclizine Hydrochloride Tablets USP, 25 mg25 mgRx Only30 Tablets. label.

PHARMACOKINETICS SECTION.


Pharmacokinetics. The available pharmacokinetic information for meclizine following oral administration has been summarized from published literature.. Absorption. Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at median max value of hours post-dose (range: 1.5 to hours) for the tablet dosage form. Distribution. Drug distribution characteristics for meclizine in humans are unknown.. Metabolism. The metabolic fate of meclizine in humans is unknown. In an in vitro metabolic study using human hepatic microsome and recombinant CYP enzyme, CYP 2D6 was found to be the dominant enzyme for metabolism of meclizine.The genetic polymorphism of CYP2D6 that results in extensive-, poor-, intermediate- and ultrarapid metabolizer phenotypes could contribute to large inter-individual variability in meclizine exposure.. Elimination. Meclizine has plasma elimination half-life of about 5-6 hours in humans.

SPL UNCLASSIFIED SECTION.


Absorption. Meclizine is absorbed after oral administration with maximum plasma concentrations reaching at median max value of hours post-dose (range: 1.5 to hours) for the tablet dosage form.

WARNINGS SECTION.


WARNINGS. Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving car or operating dangerous machinery.Patients should avoid alcoholic beverages while taking this drug.Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.. Usage in Children Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended in children under 12 years of age.. Usage in Pregnancy. Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine increases the risk of abnormalities when administered during pregnancy. Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine, or any other medication, should be used during pregnancy only if clearly necessary.